A Post Market Clinical Follow Up Study to Assess Perfectha Subskin Lid

• Research type

  Research Study

• Full title

  A Post Market Clinical Follow Up (PMCF) Study to Assess the Safety and Efficacy of Use of Perfectha Subskin Lidocaine in the Treatment of Significant Loss of Volume in the Cheeks, Jawline and/or Chin

• IRAS ID

  323072

• Contact name

  Stuart Boothman

• Contact email

  sboothman@sinclair.com

• Sponsor organisation

  Sinclair Pharmaceuticals Ltd

• ISRCTN Number

  ISRCTN63865080

• Duration of Study in the UK

  1 years, 8 months, 30 days

• Research summary

  Summary of Research
  This study is a Post Market Clinical Follow Up study, aims to generate a coherent clinical data set to demonstrate the efficacy and safety of Perfectha Subskin Lidocaine as a treatment for significant loss of volume in the cheeks, jawline and/or chin.
  Cumulative changes over time in multiple structural facial tissue layers lead to a change in morphology of the entire face in terms of shape, proportions, and topography. Integration of volume replacement into the surgical and non-surgical therapeutic algorithm as a treatment for volume loss during aging is the most important recent development in field of facial rejuvenation. The key molecule involved in skin moisture is hyaluronic acid (HA), a glycosaminoglycan (GAG) with a unique capacity to bind and retain water molecules. During facial aging, the most dramatic histochemical change observed is the marked disappearance of epidermal HA , while dermal HA is still present.
  Perfectha Subskin Lidocaine is indicated for significant loss of volume in areas such as cheekbones, chin, jawline, temples, forehead, bridge of the nose and hands. The device is intended to be administrated via injection into the deep subcutaneous fat tissue and/or into the superpatriots zone by an authorized health professional. Lidocaine is a component within the gel, included to reduce pain resulting from injection during the treatment.
  The study will be conducted in 2 study sites located in the UK. The study consists of 6 visits to assess efficacy and safety at month 1, 3,6,9,12, and 18. The trial requires 60 subjects that complete the study visits. 23 subjects will be assigned to each treatment group (i.e., cheeks, jawline or chin). The subject will have a primary treatment area and that will be the treatment group they will be assigned to. Male or female patients between the ages of 25 and 65 years of age inclusively across a range of Fitzpatrick skin types presenting significant loss

  Summary of Results
  Perfectha Subskin Lidocaine is intended for reconstructive purposes in the face, when treatment of volume losses in cheeks, jawline and/or chin using non-surgical methods is desired.
  The resorbable hyaluronic acid gel implant with added local anaesthetic Lidocaine was used by registered healthcare professionals in accordance with the instructions for use. Subjects, investigators, and independent assessors (on site and off site) collected data for analysis over 18 months. Off-site, independent assessors analysed images after the complete upload by both UK sites. The study design and two UK specialist clinics received ethics approval. The oversight was delegated by Sinclair Ltd. to a CRO (contract research organisation).
  69 subjects were enrolled in the investigation. Improvements were scored with evaluation scales used in aesthetic research.
  Of all enrolled subjects with a valid (global aesthetic improvement) GAIS score at month 3 (67 subjects), 95.5% of subjects showed overall facial improvement at 3 months. The primary efficacies were 100% for mid-face treatment, 75% for treated jawline, and 88.9% for chin. In subjects in whom more than one area was treated, the proportions of achieving an improvement at 3 months were 94.9% for midface treatment, 94.3% for jawline treatment and 100% for chin treatment.
  Of the entire group of enrolled subjects, there were injection site reactions that were qualified as adverse events (n=14). Other adverse events related to study treatment were immune-mediated adverse reaction, headache, hypoaesthesia (diminished sensation), acne (n=7). There were no device deficiencies.
  Subjects scored a median of 40 on the numeric pain distress scale (up to 100) for their treatments. Satisfaction among the two investigators with the device and its usability was high.
  Most of the injection site reactions for all treatments were mild. The signs recorded by the subjects in their treatment diaries were transitory.
  Over the 18-month duration of study period, a decline in effect was observed by independent evaluators for all treatments between three and nine months. There was an increase in the improvements rates at 12 months. The rate of improvements after treatment was highest for midface at 18 months compared to jawline and chin. In the subjects´ own assessment, the decline of improved GAIS compared to baseline by nine months was also followed by an increase at 12 months. Rates of improvement at 18 months (totaling “improved”, “much improved” and “very much improved”) were 76.9% for midface treatments, 59.3% for treated jawlines and 57.7% for treated chins when assessed by independent evaluators; these rates were 69.2%, 59.3%, 65.4%, respectively when self-assessed by subjects. A statistically significant change was observed across the evaluation periods in all subjects based on self-assessment (midface, jawline, chin).
  The final analysis showed that Perfectha Subskin Lidocaine was effective and safe in its in-label use to treat volume losses in midface, jawline and chin.

• REC name

  HSC REC B

• REC reference

  22/NI/0185

• Date of REC Opinion

  22 Dec 2022

• REC opinion

  Further Information Favourable Opinion